fMRI of Language Recovery Following Stroke in Adults

Completed

Phase N/A Results N/A

Trial Description

The purpose of this study is to test the effectiveness of constraint-induced aphasia therapy.

Detailed Description

Aphasia (difficulty speaking) is one of the most dreaded consequences of stroke. It is associated with high mortality and severe motor, social, and cognitive disability. During the past decade, therapies administered by stroke teams have made great strides in limiting the damage due to a stroke. Unfortunately, progress in aphasia rehabilitation has not experienced the same rapid advancement. Evidence suggests that the brain may have untapped potential for recovery of aphasia after stroke.
Using functional magnetic resonance imaging (fMRI), researchers now are able to examine the areas of the brain that are responsible for language recovery after stroke. Such data may explain how the brain recovers after stroke, and may lead to new therapies to help individuals who have suffered an aphasia-causing stroke.
In this study, researchers will examine the changes the brain undergoes while recovering from an aphasia-causing stroke and the mechanisms that underlie such recovery, and test the effectiveness of a new and promising method of aphasia rehabilitation called constraint-induced aphasia therapy (CIAT). The scientists will perform fMRI studies of brain activation in people who have suffered an aphasia-causing stroke in order to better understand the underlying mechanisms of recovery from aphasia. Specifically the researchers will compare language activation between adults with stroke and children with perinatal and postnatal stroke (from previous studies); map changes in language activation, characterize the patterns of language reorganization that occur following stroke; and use the fMRI measures to assess recovery using CIAT.
The study will last one year, during this time participants will have language testing to evaluate the degree of aphasia and its recovery; and five fMRI scans scheduled at 2 weeks, 6 weeks, 12 weeks, 26 weeks, and 56 weeks. Participants with remaining moderate aphasia will be offered a chance to participate in an extension treatment study that will last up to 3 months (STUDY).
A better understanding of brain changes during recovery from aphasia may help develop new methods to improve recovery.

Conditions

Interventions

  • CIAT Behavioral
    Other Names: CILT
    Intervention Desc: Patients are to receive constraint-induced aphasia therapy for 2 weeks at 4 hours per day. Detailed description of this intervention is in Szaflarski et al., 2015 Medical Science Monitor.
    ARM 1: Kind: Experimental
    Label: Aphasia - CIAT
    Description: Patients with aphasia >1 year after left MCA stroke who will be randomized to receive CIAT

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment
  • Observation: Case-Only
  • Perspective: Prospective

Outcomes

Type Measure Time Frame Safety Issue
Primary Primary outcome measure is aphasia improvement. In young and old adults, longitudinal changes in language activation patterns will be mapped & language localization and lateralization will be determined using fMRI after stroke 2 weeks after stroke, at 5-6 weeks, 3 months, 6 months and 12 months No
Secondary In participants with stroke, changes in language activation will be mapped using fMRI 2 weeks after stroke, at 5-6 weeks, 3 months, 6 months and 12 months No
Secondary CIAT will be applied & fMRI & neuropsychological measures will be used to document the relationship between the clinical and anatomical correlates of post-stroke language recovery in people with stroke 2 weeks or at 5-6 weeks after stroke , 3 months, 6 months and 12 months No
Primary Primary outcome measure is aphasia improvement. 1 week and 3 months after intervention No

Sponsors